KBI Biopharma Inc.

About KBI Biopharma Inc.

KBI Biopharma, a JSR Life Sciences company, is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of its 500+ client partners, KBI works closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Recognized for quality manufacturing, KBI helps clients advance drug candidates into the clinic and beyond. KBI serves its global clients with multiple locations in Europe and the USA. www.kbibiopharma.com. 

  • US
  • 2015
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
Biopharmaceutical company
CMO/CDMO
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Primary activities
Biopharmaceutical
Contract Manufacturer
Contact info
Meet us at

CPHI Frankfurt 2022

Messe Frankfurt, Germany
1-3 November 2022

Products from KBI Biopharma Inc. (12)

  • Analytical Development

    Product Analytical Development

    KBI has successfully completed over 300 analytical projects for more than 100 clients and more than 130 distinct molecules. Our experience includes antibodies (IgG1, IgG4, IgM, FAb, ADC, Fc fusion), enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjug...
  • Antibody (cGMP production)

    Product Antibody (cGMP production)

    Up to 2,000L Bioreactor scale; Fully integrated PD program, structural & analytical development; PC & scaled-down PV studies
  • Biologic Drug Substance & Drug Product Formulation

    Product Biologic Drug Substance & Drug Product Formulation

    KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:
    Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein.
    Employing statistical design-of-experiment (DOE) to ev...
  • Cell Culture Process Development

    Product Cell Culture Process Development

    KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture derived proteins. Our team’s combined experience includes more than 50 IND submissions and more than 5 commercial launches. The KBI team has worked with protein production processes at all scales from laboratory, ...
  • cGMP Mammalian Production

    Product cGMP Mammalian Production

    Up to 2,000L Bioreactor scale; Fully integrated PD program, structural & analytical development; PC & scaled-down PV studies
  • cGMP Microbial Production

    Product cGMP Microbial Production

    KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical, clinical and commercial supply.

    KBI’s experienced team produces high quality therapeutics and vaccines through proc...
  • cGMP Protein and Antibody Purification

    Product cGMP Protein and Antibody Purification

    KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical, clinical and commercial supply.
  • Fermentation Process Development

    Product Fermentation Process Development

    KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture derived proteins. Our team’s combined experience includes more than 50 IND submissions and more than 5 commercial launches. The KBI team has worked with protein production processes at all scales from laboratory, ...
  • Formulation Development

    Product Formulation Development

    KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:
    Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein.
    Employing statistical design-of-experiment (DOE) to ev...
  • Process Characterization and Process Validation

    Product Process Characterization and Process Validation

    Scale-down process characterization studies performed using a qualified scale-down model are a critical part of licensure applications for biologics. KBI has significant expertise in the design and execution of these studies to enable clients to define their process control strategy to take forward into manuf...
  • Protein Analysis including Mass Spectrometry

    Product Protein Analysis including Mass Spectrometry

    Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients. Our expert team brings decades of experience in protein and peptide ...
  • Protein Characterization

    Product Protein Characterization

    Protein characterization is at the heart of KBI’s service offerings. We offer a comprehensive range of analytical, biophysical, mass spectrometry, and biological assay capabilities. KBI’s scientists expertly apply these technologies and interpret the data to deliver the right information needed to s...